United States Patent 5,607,669: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,607,669, hereafter referred to as the '669 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent, owned by Genzyme and exclusively licensed to Daiichi Sankyo, pertains to a specific compound and its applications, particularly in the treatment of diabetes mellitus.
Background of the Patent
The '669 patent was granted for a compound known as colesevelam hydrochloride, which is marketed under the trade name Welchol®. This medication is used to treat type 2 diabetes and also has applications in managing cholesterol levels[2].
Scope of the Patent
Compound and Composition
The patent specifically covers colesevelam hydrochloride, a bile acid sequestrant. This compound is designed to bind bile acids in the gastrointestinal tract, which in turn helps in lowering cholesterol levels and improving glycemic control in patients with type 2 diabetes[2].
Claims
The claims of the '669 patent are detailed and specific, outlining the composition, method of preparation, and use of colesevelam hydrochloride. Here are some key aspects:
- Composition Claims: These claims define the chemical structure and formulation of colesevelam hydrochloride.
- Method of Preparation Claims: These outline the processes involved in synthesizing the compound.
- Use Claims: These specify the therapeutic uses of the compound, including its role in treating diabetes mellitus and managing cholesterol levels[2].
Patent Landscape
Ownership and Licensing
The '669 patent is owned by Genzyme, with Daiichi Sankyo holding an exclusive license for its use in the United States. This licensing arrangement is crucial for the commercial exploitation of the patent[2].
Related Patents
The '669 patent is part of a family of patents related to colesevelam hydrochloride. Other patents, such as the '675 patent, also cover various aspects of this compound and its applications. These patents collectively form a robust intellectual property portfolio for the drug Welchol®[2].
Global Patent Family
Using resources like the Global Dossier provided by the USPTO, one can see the patent family for the '669 patent, including related applications filed at participating IP Offices. This tool helps in understanding the global scope and status of the patent[1].
Legal and Regulatory Aspects
FDA Approvals and ANDA Filings
The '669 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), which is a critical database for generic drug approvals. Generic manufacturers, such as Impax and Glenmark, have filed Abbreviated New Drug Applications (ANDAs) with the FDA, which include certifications regarding the '669 and '675 patents. These filings have led to legal disputes over patent infringement[2].
Infringement and Litigation
The owners of the '669 patent have taken legal action against generic manufacturers who have filed ANDAs, alleging patent infringement. These cases highlight the importance of the patent in protecting the intellectual property rights of the original drug developers[2].
Search and Analysis Tools
USPTO Resources
To conduct a thorough analysis of the '669 patent, one can use various tools provided by the USPTO, such as the Patent Public Search tool, which offers enhanced access to prior art and related patent documents. The Common Citation Document (CCD) application is also useful for consolidating citation data from multiple patent offices[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can provide detailed information on claims from U.S. patents, including those related to the '669 patent. This dataset helps in analyzing the scope and dependency relationships between claims[3].
Economic and Market Impact
Market Dominance
The '669 patent, along with other related patents, has enabled Daiichi Sankyo to maintain market dominance for Welchol®. The exclusivity provided by these patents has been crucial in preventing generic competition and ensuring significant revenue streams[2].
Competitive Landscape
The pharmaceutical market for diabetes and cholesterol management is highly competitive. The '669 patent and its associated intellectual property portfolio play a critical role in differentiating Welchol® from other treatments and maintaining its market position.
Key Takeaways
- Compound and Composition: The '669 patent covers colesevelam hydrochloride, a bile acid sequestrant used in treating diabetes and managing cholesterol.
- Claims: The patent includes detailed claims on composition, method of preparation, and therapeutic use.
- Ownership and Licensing: Genzyme owns the patent, with Daiichi Sankyo holding an exclusive license.
- Legal and Regulatory Aspects: The patent is listed in the Orange Book and has been the subject of ANDA filings and subsequent litigation.
- Search and Analysis Tools: USPTO resources like Patent Public Search and the CCD application are essential for analyzing the patent.
- Economic and Market Impact: The patent has significant economic implications, enabling market dominance for Welchol®.
FAQs
Q: What is the main compound covered by the '669 patent?
A: The main compound covered by the '669 patent is colesevelam hydrochloride.
Q: What are the therapeutic uses of colesevelam hydrochloride?
A: Colesevelam hydrochloride is used to treat type 2 diabetes and manage cholesterol levels.
Q: Who owns the '669 patent and who has the exclusive license?
A: Genzyme owns the '669 patent, and Daiichi Sankyo has the exclusive license for its use in the United States.
Q: What is the significance of the '669 patent being listed in the Orange Book?
A: Being listed in the Orange Book indicates that the patent is recognized by the FDA as a barrier to generic competition for the drug Welchol®.
Q: How can one analyze the scope and claims of the '669 patent?
A: One can use USPTO resources such as the Patent Public Search tool and the Patent Claims Research Dataset to analyze the scope and claims of the '669 patent.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- BNA - Case 1:10-cv-00997-UNA Document 1 Filed 11/19/10: https://op.bna.com/hl.nsf/r?Open=deln-8bgmak
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Canadian Patents Database - Patent 2586023 Summary: https://www.ic.gc.ca/opic-cipo/cpd/eng/patent/2586023/summary.html?wbdisable=true
- PubChem - Patent US-4217429-A: https://pubchem.ncbi.nlm.nih.gov/patent/US-4217429-A
